METHYLPREDNISOLONE tablet

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE - UNII:X4W7ZR7023)

可用日期:

Zydus Lifesciences Limited

INN（国际名称）:

METHYLPREDNISOLONE

组成:

METHYLPREDNISOLONE 4 mg

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

Methylprednisolone tablets are indicated in the following conditions: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the first choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy mineralocorticoid supplementation is of particular importance). Congenital adrenal hyperplasia Nonsuppurative thyroiditis Hypercalcemia associated with cancer As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: Rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy) Ankylosing spondylitis Acute and subacute bursitis Synovitis of osteoarthritis Acute nonspecific tenosynovitis Post-traumatic osteoarthritis Psoriatic arthritis Epicondylitis Acute gouty arthritis During an exacerbation or as maintenance therapy in selected cases of: Systemic lupus erythematosus Systemic dermatomyositis (polymyositis) Acute rheumatic carditis

產品總結:

Methylprednisolone tablets USP, are available in the following strengths and package sizes: Methylprednisolone tablets USP, 4 mg are white to off-white, oval-shaped, flat-faced, beveled-edge tablets, debossed with '916' on one side and quadrisect on other side and are supplied as follows: NDC 70771-1348-1 in bottle of 100 tablets NDC 70771-1348-5 in bottle of 500 tablets NDC 70771-1348-3 in unit-of-use cartons of 21 tablets Methylprednisolone tablets USP, 8 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '917' on one side and bisect on other side and are supplied as follows: NDC 70771-1349-8 in bottle of 25 tablets NDC 70771-1349-1 in bottle of 100 tablets NDC 70771-1349-5 in bottle of 500 tablets NDC 70771-1349-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 16 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '918' on one side and quadrisect on other side and are supplied as follows: NDC 70771-1350-7 in bottle of 50 tablets NDC 70771-1350-1 in bottle of 100 tablets NDC 70771-1350-5 in bottle of 500 tablets NDC 70771-1350-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Methylprednisolone tablets USP, 32 mg are white to off-white, oval-shaped, biconvex tablets, debossed with '919' on one side and bisect on other side and are supplied as follows: NDC 70771-1351-8 in bottle of 25 tablets NDC 70771-1351-1 in bottle of 100 tablets NDC 70771-1351-5 in bottle of 500 tablets NDC 70771-1351-4 in unit-dose blister cartons of 100 (10 x 10) unit-dose tablets Store at 20° to 25° C (68° to 77° F) [See USP Controlled Room Temperature].  

授权状态:

Abbreviated New Drug Application

产品特点

METHYLPREDNISOLONE - METHYLPREDNISOLONE TABLET
ZYDUS LIFESCIENCES LIMITED
----------
METHYLPREDNISOLONE TABLETS, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1348-1 in bottle of 100 tablets
Methylprednisolone tablets, USP
R
only
100 tablets
NDC 70771-1349-8 in bottle of 25 tablets
Methylprednisolone tablets, USP
R
only
25 tablets
x
x
NDC 70771-1350-7 in bottle of 50 tablets
Methylprednisolone tablets, USP
R
only
50 tablets
x
NDC 70771-1351-8 in bottle of 25 tablets
Methylprednisolone tablets, USP
R
only
25 tablets
METHYLPREDNISOLONE
methylprednisolone tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1348
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPREDNISOLONE -
UNII:X4W7Z R7023)
METHYLPREDNISOLONE 4 mg
x
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STARCH, CORN (UNII: O8232NY3SJ)
PRODUCT CHARACTERISTICS
COLOR
WHITE (WHITE TO OFF-WHITE)
SCORE
4 pieces
SHAPE
OVAL (OVAL)
SIZE
8mm
FLAVOR
IMPRINT CODE
916
CONTAINS
PACKAGING
# ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1348-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
05/01/2018
2
NDC:70771-
1348-5
500 in 1 BOTTLE; Type 0: Not a Combination
Product
05/01/2018
3
NDC:70771-
1348-3
1 in 1 CARTON
05/01/2018
3
21 in 1 BLISTER PACK; Type 0: Not a Combination
Product
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA206751
05/01/2018
METHYLPREDNISOLONE
methylprednisolone tablet
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1349
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH STRENGTH
METHYLPREDNISOLONE (UNII: X4W7ZR7023) (METHYLPRE